Use of Repetitive Facilitative Exercise Program in Established Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Billie A. Schultz, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01574599
First received: April 6, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to assess whether a novel therapy approach (repetitive facilitative exercise (RFE)) is more effective than conventional rehabilitation in facilitating the recovery of upper extremity function following stroke.


Condition Intervention
Stroke
Other: Occupational therapy- Repetitive Facilitative Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Evaluation of a Repetitive Facilitative Exercise Program for Adults With an Established Stroke and Upper Extremity Impairment

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Fugl-Meyer Arm score [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motor Activity Log [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]
  • 9-Hole Peg Test [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]
  • Box and Block test [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]
  • Grasp strength [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]
  • Active Range of motion of shoulder flexion, wrist extension, and index finger extension [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]
  • Overall patient satisfaction [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Repetitive Facilitative Exercise
Repetitive facilitative exercise therapy protocol including 40 min of RFE and 20 minutes of task-specific activity. 3 treatment sessions weekly for a total of 4 weeks.
Other: Occupational therapy- Repetitive Facilitative Exercise
No Intervention: Conventional Therapy Program

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age greater than 18 years
  • Having a single ischemic or hemorrhagic hemispheric stroke of more than 6 months duration
  • The ability to selectively demonstrate active extension of at least 10 degrees at the metacarpo-phalangeal joint and the interphalangeal joints and 20 degrees at the wrist
  • Capable of effectively participating in the study

Exclusion Criteria:

  • Upper extremity contracture/pain that interfere with study technique
  • Pre-existing upper extremity neurologic or orthopedic disorders
  • Unstable medical condition
  • BMI > 35
  • Active treatment of condition during 3 months prior to enrollment in study (botulinum toxin, therapy, tendon release, etc.)
  • Language or cognitive/perceptual deficits or scheduling problems that would limit participation
  • Inability to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574599

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Billie A Schultz, MD    507-255-3166    schultz.billie@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Billie Schultz, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Billie A. Schultz, MD; Senior Associate Consultant in Department of Physical Medicine and Rehabilitation, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01574599     History of Changes
Other Study ID Numbers: 11-005596
Study First Received: April 6, 2012
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Stroke
weakness
rehabilitation
Stroke greater than 6 months prior with associated upper extremity impairment

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014